A Phase II Double-Blind Study of Delavirdine Mesylate ( U-90152 ) in Combination With Zidovudine ( AZT ) and/or Didanosine ( ddI ) Versus AZT and ddI Combination Therapy
NCT00000803 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 471
Last updated 2021-11-04
Summary
To determine the safety and anti-HIV activity of delavirdine mesylate ( U-90152 ) in combination with zidovudine ( AZT ) and/or didanosine ( ddI ) versus AZT/ddI combination.
U-90152 has demonstrated anti-HIV activity. Since the combination of this drug with either AZT or ddI has synergistic inhibitory activity against HIV-1 in vitro, and triple therapy appears to have greater inhibitory activity against HIV-1 in vitro than dual therapy, the use of U-90152 in combination with AZT and/or ddI may improve the benefits of these drugs in persons with HIV disease.
Conditions
- HIV Infections
Interventions
- DRUG
-
Delavirdine mesylate
- DRUG
-
Zidovudine
- DRUG
-
Didanosine
Sponsors & Collaborators
-
National Institute of Allergy and Infectious Diseases (NIAID)
lead NIH
Principal Investigators
-
Friedland G
-
Fischl MA
-
Pollard R
Study Design
- Purpose
- TREATMENT
- Masking
- DOUBLE
Eligibility
- Min Age
- 13 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Completion
- 1997-03-31
Countries
- United States
- Puerto Rico
Study Locations
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